Conflict of Interest in Research Disclosure Instructions

What do I need to disclose in my Conflict of Interest in Research Disclosure?

New conflict of interest regulations require some changes to the information that
you must disclose in your Conflict of Interest in Research Disclosure.
Unless otherwise specified, the changes outlined below will apply to all West Virginia
University investigators, regardless of funding. However, certain requirements
will apply only to those who receive NIH or other PHS funding
,or who plan to apply for such funding. This reference guide can help as you prepare
to submit your disclosure.

Institutional Responsibilities

One important change is a new requirement that you disclose financial interests that
reasonably appear to be related to your Institutional Responsibilities, not just
those financial interests that are related to your research. The phrase institutional responsibilities is understood to mean all of the activities that you are required
to perform in fulfilling your obligations to West Virginia University (WVU), including
your sponsored activities(such as sponsored research or service projects), teaching,
University administrative duties, clinical practice, and other University activities.

To understand what is meant by “related to your institutional responsibilities,”
you should think about your outside activities that are associated with your area
of professional expertise, or that are related to your role at the University.
Ask yourself, “Am I being asked to participate in this outside activity because
I am a professional in my field at West Virginia University?” If the answer is
“Yes,” then it may reasonably appear that the requested activity is “related to
your institutional responsibilities.” By this measure, any consultation in your
area of professional expertise should be disclosed. However, if, for example, you
are an orthopedist with a family business that imports rugs, that would not need
to be disclosed. Keep in mind that “relatedness” is not always a bright-line determination.
You should use your judgment when deciding what needs to be disclosed; but when
in doubt, err on the side of transparency.

Financial Interests

As before, you must disclose Financial Interests of any amount that are held or received
by you or your Family (see below). However, the new requirements mandate broader
disclosures than before. For example, Financial Interests now include remuneration
from, and other relationships with, not-for-profit as well as for-profit entities.
Financial Interests fall into several categories:

Compensation/Remuneration – You must disclose all non-WVU salary and payments for services (such as consulting
fees, honoraria, etc.) received by you or your family from outside entities,
including not-for-profit as well as for-profit entities, that reasonably appear
to be related to your institutional responsibilities.

You should
NOT include:

salary or other remuneration from the University (other than royalty payments);

income from seminars, lectures or teaching sponsored by a Federal, state or local
government agency, a U.S. institution of higher education, an academic teaching
hospital, a medical center, or a research institute that is affiliated with
a U.S. institution of higher education;

income from service on advisory committees or review panels for a Federal, state
or local government agency, a U.S. institution of higher education, an academic
teaching hospital, a medical center, or a research institute that is affiliated
with a U.S. institution of higher education.

Equity interests – You must disclose any stock, stock option, or other ownership interest in any
outside entities, held by you or your family, that reasonably appear to be related
to your institutional responsibilities.

You should
NOT include:

equity held in diversified financial holdings that you or your family do not
directly control, influence or manage, such as mutual funds and retirement
accounts.

Royalty Payments – You must disclose any payments to you or your family from intellectual property
rights that reasonably appear to be related to your institutional responsibilities,
such as royalties, license fees, or similar payments. Be sure to include payments
received either directly from an outside entity, which includes not-for-profit
as well as for-profit entities, or through the University (such as through a
University license agreement).

PHS researchers must also include royalties or other income received from an
independent publishing company arising out of authoring, editing or reviewing
publications (print or electronic).

Special Relationships – You must disclose if you or your family hold any directorship, management role,
or other special relationship(s) with an outside entity, including not-for-profit
as well as for-profit entities, having the potential for personal material gain,
if the role or relationship reasonably appears to be related to your institutional
responsibilities.

Travel – Some travel disclosures are required for all investigators. In addition, if
you are funded by the PHS or plan to apply for such funding, you must
disclose more broadly all reimbursed or sponsored travel that reasonably appears
to be related to your institutional responsibilities. Your disclosure must include:
the purpose of the travel, the identity of the sponsor or organizer, the duration
of travel and approximate value.

You should
NOT include:

travel funded through the University and charged to a sponsored project or departmental
account, or

travel that is reimbursed or sponsored by a Federal, state or local government
agency, a U.S. institution of higher education, an academic teaching hospital,
a medical center, or a research institute that is affiliated with a U.S. institution
of higher education.

Other – You must disclose any other financial interests held by you or your family
that reasonably appear to be related to your institutional responsibilities (e.g.,
certain intellectual property rights).